By Adam West, Course and Curriculum Manager at CriticalPoint
I have always felt safer in a radiopharmacy than in any hazardous drug buffer room.
However, it may not be for the reasons you might think. Despite radiopharmaceuticals being radioactive agents, the radiation received during treatment is very low and considered safe when small amounts are used. The amount of radiation is similar to diagnostic scans, which are also considered safe. In fact, an airline pilot is exposed to more occupational radiation hazards over the course of their career than that of a radiopharmaceutical compounder or the patient receiving specific treatment (a known fact since the 90s).
Are certifiers at more risk of HD exposure than pharmacy workers?
Like so many other things, it depends on the situation. Parallel to pharmacy compounders, I too have spent countless hours in controlled environments and ISO-classified cleanrooms. While we may be working in the same environments, we’re not doing the same work. However, when hazardous drugs (HDs) are present, we all face one common danger—exposure to HDs. So, who is more at risk? Before I reveal my thoughts, below are some reflections on preventing accidental exposure:
- Do you have HD exposure and awareness training programs available to your staff?
- Who receives this type of training?
- Are vendors receiving this training, or are you confirming with their management that they have received comparable training from their organizations?
- Have you thought about those who could be exposed to HDs who aren’t directly compounding?
Service and repairs on biological safety cabinets (BSCs) are the single greatest risk associated with occupational exposure for certifiers.
Despite this fact, there is a silent issue lurking in the certifier world. (Trigger warning) Many field certifiers, at least until recent times, never considered the risks when working in pharmacy HD environments. They may trust that you are watching over their safety and that you have thoroughly cleaned and decontaminated surfaces, or they haven’t been properly trained on HDs to begin with.
Although certifiers are very familiar with biological hazards, laboratory decontamination methods, and the biologics they aim to neutralize prior to service, the difficulty lies in addressing the variety of dangerous HDs and how to work in and around them. This invisible hazard may not even present an issue until long after exposure has occurred.
There is also the potential for prolonged and repeated exposure because field service may involve directly working in the highly contaminated zone (the interior BSC plenum) when changing filters or blower motor repair—something that pharmacy compounders never experience.
What keeps me up at night?
Besides the fact that four of my six children are consecutively learning to drive with each passing year, what keeps me up at night is the idea of field service and occupational exposure to HDs. Are pharmacy and certifying organizations doing enough to ensure that field technicians are properly trained and aware of the risks associated with HDs and the environments they certify? Moreover, who enforces this within the customer/vendor relationship? And should it matter or even be a topic of discussion?
No one likes to be micromanaged, and that’s not what I’m proposing in these situations. Although USP was not explicit when listing personnel (“but not limited to”) who may potentially become exposed to hazardous drugs, it is still a responsibility of entities who prepare HDs to ensure safe work practices are performed when servicing containment engineering controls.
Additionally, I would expect service vendors to adhere to the safety precautions described in USP Chapters 795, 797, and 800. Meaning, they should read and incorporate specific elements of training and competency the same way pharmacy workers must. However, if vendors are lacking in this area of personal safety, pharmacies should still include some oversight when vendors perform work within their facilities. This includes ensuring:
- proper PPE is practiced
- general safe work practices are performed (outlined by pharmacy and vendor responsibility)
- hazard communication programs are made known
- spill control practices are shared with visitors
Simply said, pharmacies cannot just trust that a field technician has had proper HD exposure and awareness training because they are credentialed, have worked in similar environments prior, or are of a reputable organization. I know that sounds harsh, and I don’t mean it to sound that way. What people don’t know is what people don’t know. Field technicians may just have their certification blinders on and trust that pharmacies are operating with no contaminated surfaces.
“It’s their job to work in these environments and not understand working in these environments,” I heard someone say once, and it couldn’t be further from the truth. Occupational hazard is a real thing with real consequences: exposure.
Why do I feel safer in radiopharmacies?
It’s because of this type of pharmacy’s approach to conscious quality (surrounding work practices) and surveillance. One obvious fact with surveillance is that radioactivity is not invisible. The facility has the means to assess in real time how well someone is doing around the hazards. Unfortunately, HD pharmacies do not have the luxury of knowing how much or how little someone has been exposed.
But what I really saw as a difference between HD and radio compounding is surveillance of my own behavior from the compounders. Radiopharmacies know where I am and what I’m doing and have communicated where I can be at any given time. This is similar to the experience I’ve had with the level of security and safety in particular laboratories (that may or may not handle bubonic plague antigens that I cannot speak further about…)
What’s strange is that, even after USP 800 was released in 2016, I could show up at a pharmacy for routine certification and practically be invited anywhere, in any room, at any time… and this was the case with many of my customers. There was no communication between us to confirm the HDs had been secured (often vials found stored on the work deck), no indication that surfaces had been decontaminated, and no disclosure of what work had been going on that day or the hazards they presented.
From an outside perspective, does this sound safe? You don’t know me from Adam. I’m not being watched to make sure I wear proper HD PPE, or don’t handle something I shouldn’t. Looking through a hazardous safety lens, this seems to be a fundamental lack of communication between the pharmacy and the vendor.
Who’s at fault?
The responsibility falls on us together. Because there are gaps in USP language, practical application, and day-to-day operation, of course there are things we haven’t thought of addressing. Regrettably, this places those unaware of HD exposure and safety precautions in a more dangerous situation.
Improper work practices can bring contamination to our own home’s doorstep. I believe that certifiers are consciously aware of this consequence and are taught that in other industry applications. But do we realize what the other does or doesn’t know? So, I’ll ask you, what keeps you up at night with your facility’s HD work practices?
If you are responsible for vendors or visitors at your facility or if you are a certification vendor, consider our training to assure proper safety protocols are in place at your organization!